This invention relates to a computer-based method of determining medical treatment values that takes into account present medical practices and anticipated changes in medical practices, particularly those intended to reduce drug dosing errors and the time required to accurately determine medical treatment values, such as drug dosages.
Ordering appropriate doses of medications for various indications is a complex, error prone process. Each drug has its own unique therapeutic profile which includes its various dosage forms, routes of administration, duration of action and potency. Certain drugs also have specific instructions related to exposure to light, safe handling, secure storage, and safe and secure disposal after use. Some of these guidelines are mandated by regulatory or accrediting agencies. Routes of administrations are varied, and including oral pills or liquids, parenteral IV or IM routes including infusions, aerosols, intra nasal, nasogastric tubes, and the like. Writing a prescription for an oral tablet, for example, might include determining the tablet strength most appropriate to the total amount to be administered, whether to take half a pill, whole pill or one and a half pills, the frequency of administration, expressed as 3 times per day or every 6 hours, etc. This information is conveyed as text on written or electronic prescriptions in a standard format such as: Hydralazine 50 mgs ½ tablet three times per day followed by the duration of therapy, if limited.
This system was well suited to past medical practice regimes, in which patients tended to see the same doctor for most conditions, and the doctor had a limited number of drugs that could be prescribed on a regular basis. When this patient entered a hospital for specialized care, that same doctor would frequently visit the patient along with the specialist involved and would help assure a smooth continuum of care. This situation has changed drastically as the number of medications and indications have grown exponentially. In addition, the introduction of emergency departments and hospitalists along with hospital-based nurses has significantly changed the nature of medical practice, so that no one person can possibly know all of the potential medications that could be ordered and prescribed for any given patient. The bedside nurse is especially impacted because of the requirements to administer drugs correctly, explain potential side effects to the patient or families, and document knowledge of each drug administered as part of the hospital Joint Commission and other regulatory and compliance mandates.
The substantial scope and breadth of the potential information involved is overwhelming, especially when one considers that there is almost no time for a busy nurse to research the totality of the relevant information in real time at the bedside. Part of the solution is to develop a coding system that facilitates immediate, real time access to a drug database that encompasses the totality of relevant information presented in a concise and clinically relevant way. In addition to these general changes, the hospital environment is rapidly evolving from a documents-based information to digital systems. This means that information presented in text formats would need to be read and then entered as digital data so that it can be accessed appropriately anywhere in the electronic record. The problems caused by this disconnect between text-based systems and digital ones is best demonstrated when a patient goes from their home or nursing facility to a hospital. There, the receiving institution tries to “reconcile” the medications to decide which should be continued or modified during the period of treatment by the receiving institution. For example, a nurse may be required to read, understand and implement a treatment regimen based on a list of medications and doses written on scraps of paper brought in by a patient, or a lengthy list of medications from a nursing home. Scanning a written list does enter the information into the medical record, but not in an electronically usable format since it is not granular, digital information. Even if legibility is not an issue, the physician who must make the final prescribing decisions needs to know that each medication to be continued is in the appropriate dose for the particular circumstances of the hospital stay.
Since a hospitalist will be seeing patients usually treated by many different physicians it is not possible to know the nuances of dosing represented by the drug list being presented. Similarly, the physician may delegate the responsibility of dose checking to a nurse or pharmacist involved with that patient's care. There is clearly a need to simplify and automate this entire process both to decrease errors and to reduce the amount of time and professional assets that are involved.
The solution is to develop a coding system that recognizes a drug name, dose and frequency of administration so that an entire prescription can be conveyed by a single code, thus allowing the information to be entered by a barcode reader into an electronic medication administration record (“eMar”). The eMar then translates the code back into the original text, allowing rapid evaluation of the need to continue the medication or to modify the dosages. Also, prescriptions with such a code displayed could digitally convey the key information to a pharmacy computer, again helping automate the process and reduce the need to read the writing on the prescription itself. Using this system, prescriptions can be written by a single code number or modified by changing a single digit of the code without requiring the entire information to be rewritten. Each change in code entered thus results in a new barcode. The code also facilitates direct communication of, for example, side effects, indications and the like directly from the medication to the patient. When required, the information can be translated into a specific language for each patient. At the hospital level this capability would help with meeting meaningful use requirements for optimum reimbursement without requiring significant time to be incurred by nurses looking up information in standard references for medications that they may not be familiar with. One aspect of the solution is to develop a medication potency scale such as “level 1-10” that delineates where a prescription or drug order resides within the entire range of appropriate dosage for a particular medication and indication. A typical prescription would be for the middle of the range. As an example, Hydralazine Level 5 prescription would then connote all of the information illustrated above. Since the drug itself has an NDC Code as well, all of the information can then be condensed into a single barcode that can immediately enter the entire drug profile into the eMar. Conversely, any prescription with the NDC Code or other unique identification associated with it can be scanned and expressed as text for communication to a patient or pharmacist. Writing prescriptions for oral medications is straightforward, since many times the order is for products that have already been produced, or can be reconstituted in a straightforward manner.
However, frequently in hospital settings more complex issues surface when ordering, preparing and administrating medications in real time acute clinical settings. An example is ordering, preparing and administering medications for delivery as infusions. Many critical medications are best delivered by large and small pump infusion devices. There are various reasons why this is true, but one of the principal functions of a pump infusion device is to control the rate of delivery of potent medications in infants, pediatric patients and adults. The typical infusion pump is “programmable” at the bedside, allowing data input including the name of the medication, concentration, volume, etc. Infusion pumps have both manual settings for simple parameters such as mLs per minute or per hour and volume.
Because of errors that have occurred with setting these pumps in actual clinical situations, software has been developed that includes “drug libraries” which have standardized medications, concentrations, delivery settings and alerts that indicate if a drug is being delivered outside of accepted ranges based on patient's weight and clinical setting. These libraries tend to be specific for various aspects of clinical care and settings such as the NICU, ICU, Surgery, etc. Typically there may be up to 9-10 libraries representing the full spectrum of care in a large medical center. Each pump has to be individually programmed with the initial library information and updated as needed. They can also be programmed by WiFi as part of an enterprise electronic medication delivery system. Considerable time, resources and expenses are associated with this process. In addition, when infusions are mixed at the pharmacy level and arrive at the bedside, the library must be accessed and the particular drug, concentration, and volume entered into to the appropriate library in the pump. This process is subject to errors, to the extent that some hospitals actually have special teams that go to the point of care to “set the pumps” in attempt to minimize potential errors from a bedside nurse setting the pump incorrectly.
Also, in research situations with new drugs or new doses for existing drugs, the programmed library rarely includes these drugs. There is also clearly a need to simplify and streamline this process as well. Ordering or double-checking infusions is particularly problematic since orders are typically given in micrograms/kg/minute, and the pumps are set for mLs per hour. There is no simple way of conveying the potency of drug delivery at any particular time due to the fact that the doses as ordered might be a small dose (2 mics/kg/minute) for one drug and indication, and a large dose for another. A 1-10 scale as described above would greatly facilitate ordering and communication in this error prone area.
Recently a system has been developed that standardizes the indication, dose, dilution, and rate of administration, as exemplified in Patent Application Publication US 2011/0264462, to James B. Broselow. Because the Broselow system represents all of the parameters needed to do an initial infusion pump setting, there is now the possibility to automate the entire process. A database can be developed that contains a specific identifier (number and/or letter) for every combination of drug, starting dose and dose range for each indication, dilutions and final volume.
This “identifier” can thus represent all of the information needed to automatically set the pump to an initial setting appropriate for that patient's specific clinical need. Included in this identifier is the potency represented by the “scale” described above. Software in the pump converts that number into a specific initial output and, with pumps containing drug libraries, it can also display drug name, output, etc. as if the library had been the source of the information. The potency at any point in time can be displayed on the pump itself by showing the scale either visually or as a number or percent. The identifier can be entered manually by a keyboard, wireless from a mobile device or an inline system or, preferentially, by barcode scanning or QR code capture directly into the device.
A digital system that includes an identifier number that encompasses all of the medical information needed to prescribe or deliver a dose of a particular drug is therefore needed. Such a system provides exact preparation and administration information when needed, presented as a barcode to communicate both to electronic medical systems as well as to specific delivery devices thus will allow automation of the entire process of medication delivery, reducing both errors and healthcare costs.